BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2211063 · Received August 5, 2011

    Report

    Report Number
    1644487-2011-01768
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2008
    Report Date
    July 7, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING THE REVIEW OF THE PT'S PROGRAMMING HISTORY, IT WAS NOTED THAT A FAULTED SYSTEM DIAGNOSTIC TEST CHANGED THE PT'S SETTINGS UNINTENTIONALLY. THE FAULT OCCURRED ON (B)(6) 2008, AND THE CHANGE WENT UNDETECTED, LEAVING THE PT AT UNINTENDED SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250 521389

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR